Abstract

Background: It is unknown whether fluid resuscitation with colloid or crystalloid in patients with severe sepsis or septic shock is associated with an improvement in clinical outcome. This randomized controlled trial determined the feasibility of conducting a large trial testing resuscitation with pentastarchvs normal saline in early septic shock, powered for a difference in mortality.

Methods: At three Canadian and one New Zealand academic centre, 40 patients with early septic shock defined by at least two systemic inflammatory response syndrome criteria, infectious source, and persistent hypotension after ≥ 1 L of crystalloid fluid were recruited. Feasibility measures were patient recruitment, blinding of the study fluids, and acceptability of the goal directed algorithms. Boluses of blinded normal saline or pentastarch (500 mL − maximum 3 L or 28 mL·kg−1) were administered within goal directed care for the first 12 hr.

Results: Of 161 patients screened, 121 were excluded and 40 patients were enrolled, for a recruitment rate of 0.75 patients/ site/month. Only 57% of physicians and 54% of nurses correctly guessed the study fluid (P = 0.46 andP = 0.67, respectively). The goal directed algorithms were acceptable to 97% of physicians.

Conclusion: The ability to recruit patients in this pilot randomized controlled trial was below expectations. Blinding of study fluids was adequate, and resuscitation algorithms were acceptable to most physicians. Methods to improve recruitment are required to enhance the feasibility of conducting a multicentre fluid resuscitation trial in early septic shock.

Keywords

Sources of funding and conflicts of interest: Dr. McIntyre has received unrestricted funds from Bristol Myers Squibb and Edwards Life Sciences to conduct this trial. She has also received unrestricted funds from Abbott Laboratories.

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